Emergence Delirium, Pediatric Dental General Anesthesia, Postoperative Recovery
Conditions
Keywords
Pre-emptive local anesthesia, Pediatric anesthesia, Dental anesthesia, Emergence behavior, QoR-15 Pictorial, Ambulatory surgery
Brief summary
This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.
Detailed description
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia. Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded. Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form. The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
Interventions
PROCEDUREPre-emptive Local Anesthesia
Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
DRUGArticaine Hydrochloride With Epinephrine
Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded.
Sponsors
seher orbay yasli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinician performing the local anesthesia cannot be masked. Post-anesthesia care unit assessments, including emergence behavior, pain, sedation level, and recovery quality, will be performed by an outcomes assessor blinded to group allocation.
Intervention model description
Participants will be randomized in a 1:1 ratio to either pre-emptive local anesthesia or no local anesthesia during ambulatory pediatric dental general anesthesia.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 7 to 12 years * ASA physical status I or II * Scheduled for ambulatory dental treatment under general anesthesia * Ability to understand and respond to age-appropriate pain and recovery assessment tools * Written informed consent obtained from a parent or legal guardian * Child assent obtained when appropriate
Exclusion criteria
* Known allergy or contraindication to local anesthetic agents * Developmental delay or cognitive impairment preventing assessment * Autism spectrum disorder or severe behavioral disorder * Neurological disease affecting behavior or consciousness * Chronic analgesic or sedative medication use * Severe hepatic, renal, cardiac, or respiratory disease * Emergency dental procedure * Need for postoperative hospital admission * Inability to complete postoperative assessment tools
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery | PACU minutes 0, 5, 10, 15, and 30 | Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale. The scale includes five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and consolability. Each item is scored from 0 to 4, with a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium symptoms. Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | PACU minutes 0, 5, 10, 15, and 30 | Pain will be assessed using the Faces Pain Scale-Revised. Scores range from 0 to 10, with higher scores indicating greater pain intensity. |
| Recovery Quality Before Discharge | Before discharge on day of surgery | Recovery quality will be assessed using the QoR-15 Pictorial form before discharge. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery quality. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSeher Orbay Yaşlı, Assistant Professor of Anesthe
Outcome results
None listed